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IMG-7289 in Patients With Myelofibrosis

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ClinicalTrials.gov Identifier: NCT03136185
Recruitment Status : Recruiting
First Posted : May 2, 2017
Last Update Posted : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
Imago BioSciences,Inc.

Study Description
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Brief Summary:

This is a Phase 2b open label study of an orally administered LSD1 inhibitor, IMG-7289, in patients with myelofibrosis.

This study investigates the following:

  • The safety and tolerability of IMG-7289
  • The pharmacokinetics of IMG-7289 (performed in Phase 1/2a only)
  • The pharmacodynamic effect of IMG-7289

Condition or disease Intervention/treatment Phase
Myelofibrosis Post-polycythemia Vera Myelofibrosis (PPV-MF) Post-essential Thrombocythemia Myelofibrosis (PET-MF) Primary Myelofibrosis (PMF) Drug: IMG-7289 Phase 2

Detailed Description:
With enrollment complete in Phase 1/2a, expansion into Phase 2b has occurred. New patients will be enrolled into Phase 2b study.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center, Open Label Study to Assess the Safety, Steady-State Pharmacokinetics and Pharmacodynamics of IMG-7289 in Patients With Myelofibrosis
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: IMG-7289
Single starting dose with individualized dose titrations throughout
 Drug: IMG-7289
Differentiation therapy
Other Name: LSD1 inhibitor


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events, and changes in physical examination, vital signs and laboratory parameters [safety and tolerability] [ Time Frame: Assessed from the time of first dose through 28 days after end of treatment. ]
    as measured by the frequent monitoring of: adverse events, physical examination and vital signs and laboratory parameters.


Secondary Outcome Measures :
  1. Drug Concentration (performed in Phase 1/2a only) [ Time Frame: Up to 3 months. ]
    as measured by Cmin sampling.

  2. Spleen Volume [ Time Frame: Baseline to each visit where the variable is measured. ]
    Reduction in spleen volume based on MRI (or CT)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >18 years
  • Diagnosis of either PMF per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms, PPV-MF or PET-MF per the IWG-MRT
  • High or intermediate-2 risk disease, as defined per protocol

Exclusion Criteria:

  • Receiving other treatments for the condition (with exceptions and time limits)
  • Major surgery in last 4 weeks, minor surgery in the last 2 weeks
  • History of, or scheduled, hematopoietic stem cell transplant within 24 weeks of Screening
  • History of splenectomy
  • Current use of prohibited medications
  • A concurrent second active and nonstable malignancy
  • Known HIV infection or active Hepatitis B or Hepatitis C virus infection
  • Other hematologic/biochemistry requirements, as per protocol
  • Use of investigational agent within last 14 days
  • Pregnant or lactating females
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03136185


Contacts
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Contact: Jennifer Peppe +1-415-529-5055 jennifer.peppe@imagobio.com
Contact: Amber Jones amber.jones@imagobio.com

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Kristen Pettit, MD    734-647-8901    krpettit@med.umich.edu   
Australia, South Australia
Royal Adelaide Hospital Completed
Adelaide, South Australia, Australia
Italy
Azienda Ospedaliero Universitaria Careggi Recruiting
Florence, Italy
Contact: Alessandro M Vannucchi    390557947688      
United Kingdom
Guy's and St Thomas' Hospitals Recruiting
London, United Kingdom
Contact: Claire Harrison    020 7188 4259    HaematologyResearchTeam@gstt.nhs.uk   
Sponsors and Collaborators
Imago BioSciences,Inc.
Investigators
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Principal Investigator: Kristen Pettit University of Michigan
More Information
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Responsible Party: Imago BioSciences,Inc.
ClinicalTrials.gov Identifier: NCT03136185     History of Changes
Other Study ID Numbers: IMG-7289-CTP-102
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imago BioSciences,Inc.:
LSD1
Additional relevant MeSH terms:
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Polycythemia Vera
Primary Myelofibrosis
Polycythemia
Thrombocytosis
Thrombocythemia, Essential
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
 Bone Marrow Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Blood Platelet Disorders
Blood Coagulation Disorders
Hemorrhagic Disorders